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Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination Granted U.S. FDA Priority Review for First-Line Maintenance Treatment of Extensive-Stage Small Cell Lung Cancer
Target Action (PDUFA) Date set for October 7, 2025 Application based on data from IMforte, the first Phase 3 trial demonstrating statistically significant and
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"Target Action (PDUFA) Date set for October 7, 2025\nApplication based on data from IMforte, the first Phase 3 trial demonstrating statistically significant and clinically meaningful improvements in both progression-free and overall survival in the ES-SCLC first-line maintenance setting\nJazz to host investor webcast on Tuesday, June 10 at 4:30 p.m. EDT / 9:30 p.m. IST to review Zepzelca data\nFor U.S. media and investors only\nDUBLIN, June 10, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide for Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of October 7, 2025. Priority Review is granted to applications for drugs that have the potential to significantly improve the treatment, prevention, or diagnosis of serious conditions. \n\"The FDA's Priority Review designation for Zepzelca in combination with atezolizumab as a first-line maintenance treatment highlights the urgent need for new approaches and the potential benefit of Zepzelca for patients with extensive-stage small cell lung cancer, a disease with limited therapeutic options and high unmet need,\" said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. \"We are pleased to have received this review designation after presenting the IMforte trial data at ASCO 2025 with simultaneous publication in The Lancet. Together, these milestones bring us a step closer to potentially offering patients a new first-line maintenance option that could help extend the time they live without their disease progressing.\"\nThe sNDA submission is based on results from the Phase 3 IMforte trial of Zepzelca in combination with atezolizumab, which met both primary endpoints, demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to atezolizumab alone. Following induction therapy with carboplatin, et...